- EU label expansion supported by high
cure rates shown in AbbVie’s TURQUOISE-III study, a dedicated Phase
3b study of VIEKIRAX + EXVIERA without ribavirin for 12 weeks
- 100 percent SVR12 (n=60/60) achieved in
genotype 1b patients with compensated cirrhosis (Child-Pugh A); no
patients discontinued treatment due to adverse events
Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating
small molecule drugs for viral infections and liver diseases,
announced today that the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMA) has granted a
positive opinion for the use of VIEKIRAX®
(ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir
tablets) without ribavirin (RBV) in chronic hepatitis C virus (HCV)
infected genotype 1b (GT1b) patients with compensated cirrhosis
(Child-Pugh A).
Paritaprevir is Enanta’s lead protease inhibitor identified
within the ongoing Enanta-AbbVie collaboration and is one of the
direct-acting antivirals in AbbVie’s VIEKIRAX + EXVIERA treatment
regimen for chronic hepatitis C virus (HCV).
Approximately 160 million people worldwide are infected with
HCV.1 Genotype 1 is the most common type of HCV genotype,
accounting for 60 percent of cases worldwide.2 In the European
Union, the most prevalent sub-genotype is 1b, accounting for 47
percent of the estimated nine million Europeans infected with
chronic HCV. 3,4
The CHMP opinion regarding the pending application for expansion
of the label for VIEKIRAX + EXVIERA is supported by data from
AbbVie’s Phase 3b TURQUOISE-III study, which is part of AbbVie’s
larger clinical program investigating efficacy and safety in a
broad range of GT1 patients. The Phase 3b TURQUOISE‐III study is a
dedicated Phase 3 study of VIEKIRAX + EXVIERA without RBV for 12
weeks in GT1b patients with compensated cirrhosis. Results from the
TURQUOISE-III study showed 100 percent (n=60/60) of GT1b chronic
HCV infected patients with compensated cirrhosis (Child-Pugh A)
achieved sustained virologic response at 12 weeks post-treatment
(SVR12) with VIEKIRAX + EXVIERA without RBV for 12 weeks. No
patients discontinued treatment due to adverse events. The most
commonly reported adverse events (>10 percent) were fatigue (22
percent), diarrhea (20 percent) and headache (18 percent).5
On January 7, AbbVie announced that its supplemental New Drug
Application (sNDA) for a similar label expansion for VIEKIRA PAK®
in the U.S. was accepted and granted priority review by the U.S.
Food and Drug Administration (FDA).
About VIEKIRAX® +
EXVIERA® in the EUVIEKIRAX + EXVIERA is
approved in the European Union for the treatment of genotype 1
(GT1) chronic hepatitis C virus (HCV) infection, including patients
with compensated cirrhosis (Child-Pugh A). VIEKIRAX is approved in
the European Union for the treatment of genotype 4 (GT4) chronic
HCV infection.
VIEKIRAX tablets consist of the fixed-dose combination of
paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg
with ombitasvir 25mg (NS5A inhibitor), dosed once daily. EXVIERA
tablets consist of dasabuvir 250mg (non-nucleoside NS5B polymerase
inhibitor) dosed twice daily. VIEKIRAX + EXVIERA are taken with or
without ribavirin (RBV), dosed twice daily based on patient type.
VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV,
except in genotype 1a and GT4 patients with compensated cirrhosis,
who should take it for 24 weeks with RBV.
EU IndicationsVIEKIRAX is indicated in combination with
other medicinal products for the treatment of chronic hepatitis C
(CHC) in adults. EXVIERA is indicated in combination with other
medicinal products for the treatment of CHC in adults.
Important EU Safety
InformationContraindications:VIEKIRAX + EXVIERA are
contraindicated in patients with severe hepatic impairment
(Child-Pugh C). Patients taking ethinyl estradiol-containing
medicinal products must discontinue them and switch to an
alternative method of contraception prior to initiating VIEKIRAX +
EXVIERA. Do not give VIEKIRAX with certain drugs that are sensitive
CYP3A substrates or strong inhibitors of CYP3A. Do not give
VIEKIRAX and EXVIERA with strong or moderate enzyme inducers. Do
not give EXVIERA with certain drugs that are strong inhibitors of
CYP2C8.
Special warnings and precautions for use:VIEKIRAX and
EXVIERA are not recommended as monotherapy and should be used in
combination with other medicinal products for the treatment of
hepatitis C infection.
Risk of Hepatic Decompensation and Hepatic Failure in Patients
with Cirrhosis
Viekirax and Exviera are not recommended in patients with
moderate hepatic impairment (Child-Pugh B). Patients with cirrhosis
should be monitored for signs and symptoms of hepatic
decompensation, including hepatic laboratory testing at baseline
and during treatment.
ALT elevationsTransient elevations of ALT to >5x ULN without
concomitant elevations of bilirubin occurred in clinical trials
with VIEKIRAX + EXVIERA and were more frequent in a subgroup who
were using ethinyl estradiol-containing contraceptives.
Pregnancy and concomitant use with ribavirinExtreme caution must
be taken to avoid pregnancy in female patients and female partners
of male patients when VIEKIRAX with or without EXVIERA is taken in
combination with ribavirin, see section 4.6 and refer to the
Summary of Product Characteristics for ribavirin for additional
information.
Use with concomitant medicinal productsUse caution when
administering VIEKIRAX with fluticasone or other glucocorticoids
that are metabolized by CYP3A4. A reduction in colchicine dosage or
interruption in colchicine is recommended in patients with normal
renal or hepatic function. VIEKIRAX with or without EXVIERA is
expected to increase exposure of statins so certain statins need to
be discontinued or dosages reduced. Low dose ritonavir, which is
part of VIEKIRAX, may select for PI resistance in HIV co-infected
patients without ongoing antiretroviral therapy. HIV co-infected
patients without suppressive antiretroviral therapy should not be
treated with VIEKIRAX.
Adverse ReactionsMost common (>20 percent) adverse
reactions for VIEKIRAX + EXVIERA with RBV were fatigue and
nausea.
Full summary of product characteristics is available
at www.ema.europa.eu.
Globally, prescribing information varies; refer to the
individual country product label for
complete information.
About VIEKIRA PAK
USE
VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets;
dasabuvir tablets) is a prescription medicine used with or without
ribavirin to treat adults with genotype 1 chronic (lasting a long
time) hepatitis C (hep C) virus infection, including people who
have a certain type of cirrhosis (compensated).
VIEKIRA is not for people with advanced cirrhosis
(decompensated). If people have cirrhosis, they should talk to a
healthcare provider before taking VIEKIRA.
IMPORTANT SAFETY INFORMATION
When taking VIEKIRA PAK in combination with ribavirin, people
should read the Medication Guide that comes with ribavirin,
especially the important pregnancy information.
What is the most important information to know about VIEKIRA
PAK?
- VIEKIRA PAK may cause severe liver
problems, especially in people with certain types of cirrhosis.
These severe liver problems can lead to the need for a liver
transplant, or can lead to death.
- VIEKIRA PAK can cause increases in
liver function blood test results, especially if people use ethinyl
estradiol-containing medicines (such as some birth control
products).
- Ethinyl estradiol-containing medicines
(combination birth control pills or patches, such as Lo Loestrin®
FE, Norinyl®, Ortho Tri-Cyclen Lo®, Ortho Evra®; hormonal vaginal
rings such as NuvaRing®; and the hormone replacement therapy
medicine, Fem HRT®) must be stopped before starting treatment with
VIEKIRA PAK. If these medicines are used as a method of birth
control, another method must be used during treatment with VIEKIRA
PAK, and for about 2 weeks after treatment with VIEKIRA PAK ends. A
doctor can provide instruction on when to begin taking ethinyl
estradiol-containing medicines.
- A doctor should do blood tests to check
liver function during the first 4 weeks of treatment and then as
needed.
- A doctor may tell people to stop taking
VIEKIRA PAK if signs or symptoms of liver problems develop. A
doctor must be notified right away if any of the following symptoms
develop or if they worsen during treatment with VIEKIRA PAK:
tiredness, weakness, loss of appetite, nausea, vomiting, yellowing
of the skin or eyes, color changes in stools, confusion, or
swelling of the stomach area.
VIEKIRA PAK must not be taken if people:
- have certain liver problems
- take any of the following
medicines: alfuzosin hydrochloride (Uroxatral®) • carbamazepine
(Carbatrol®, Epitol®, Equetro®, Tegretol®) • colchicine (Colcrys®)
• efavirenz (Sustiva®, Atripla®) • ergot containing medicines,
including ergotamine tartrate (Cafergot®, Migergot®, Ergomar®,
Ergostat®, Medihaler®, Wigraine®, Wigrettes®), dihydroergotamine
mesylate (D.H.E. 45®, Migranal®), methylergonovine (Ergotrate®,
Methergine®) • ethinyl estradiol-containing medicines • gemfibrozil
(Lopid®) • lovastatin (Advicor®, Altoprev®, Mevacor®) • midazolam
(when taken by mouth) • phenytoin (Dilantin®, Phenytek®) •
phenobarbital (Luminal®) • pimozide (Orap®) • rifampin (Rifadin®,
Rifamate®, Rifater®, Rimactane®) • sildenafil citrate (Revatio®),
when taken for pulmonary artery hypertension (PAH) • simvastatin
(Zocor®, Vytorin®, Simcor®) • St. John’s wort (Hypericum
perforatum) or a product that contains St. John’s wort • triazolam
(Halcion®)
- have had a severe skin rash after
taking ritonavir (Norvir®)
What should people tell a doctor before taking VIEKIRA
PAK?
- If they have: liver problems other than
hep C infection, HIV infection, or any other medical
conditions.
- If they have had a liver transplant. If
they take the medicines tacrolimus (Prograf®) or cyclosporine
(Gengraf®, Neoral®, Sandimmune®), a doctor should check blood
levels and, if needed, may change the dose of these medicines or
how often they are taken, both during and after treatment with
VIEKIRA PAK.
- If they are pregnant or plan to become
pregnant or if they are breastfeeding or plan to breastfeed. It is
not known if VIEKIRA PAK will harm a person’s unborn baby or pass
into breast milk. A doctor should be consulted about the best way
to feed a baby if taking VIEKIRA PAK. Pregnant females who have
both hep C and HIV infection should talk with a doctor about
enrolling in the antiretroviral pregnancy registry.
- About all the medicines they
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements. Some medicines interact with
VIEKIRA PAK.
- A new medicine must not be started
without telling a doctor. A doctor will provide instruction on
whether it is safe to take VIEKIRA PAK with other medicines.
- When VIEKIRA PAK is finished, a doctor
should be consulted on what to do if one of the usual medicines
taken was stopped or if the dose changed during VIEKIRA PAK
treatment.
What are the common side effects of VIEKIRA PAK?
- For VIEKIRA PAK used with
ribavirin, side effects include tiredness, nausea, itching,
skin reactions such as redness or rash, sleep problems, and feeling
weak.
- For VIEKIRA PAK used without
ribavirin, side effects include nausea, itching, and sleep
problems.
These are not all of the possible side effects of VIEKIRA PAK. A
doctor should be notified if there is any side effect that is
bothersome or that does not go away.
This is the most important information to know about VIEKIRA
PAK. For more information, talk with a doctor.
People are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
Click here for full Prescribing Information,
including the Medication Guide.
If people cannot afford their medication, they should
contact www.pparx.org for assistance.
About EnantaEnanta Pharmaceuticals is a research and
development-focused biotechnology company that uses its robust
chemistry-driven approach and drug discovery capabilities to create
small molecule drugs for viral infections and liver diseases.
Enanta’s research and development is currently focused on four
disease targets: Hepatitis C Virus (HCV), Hepatitis B Virus (HBV),
Non-alcoholic Steatohepatitis (NASH) and Respiratory Syncytial
Virus (RSV).
Enanta has developed novel protease inhibitors and NS5A
inhibitors that are members of the direct-acting-antiviral (DAA)
inhibitor classes designed for use against the hepatitis C virus
(HCV). Enanta’s protease inhibitors, developed through its
collaboration with AbbVie, include paritaprevir, which is contained
in AbbVie’s marketed DAA regimens for HCV, and ABT-493, Enanta’s
next-generation protease inhibitor, which AbbVie is developing in
phase 3 studies in combination with ABT-530, AbbVie’s
next-generation NS5A inhibitor. Enanta has also discovered a
cyclophilin inhibitor, EDP-494, a novel host-targeting mechanism
for HCV, which is now in a phase 1 clinical development, and
EDP-305, an FXR agonist, which Enanta plans to advance into
clinical development for NASH later in 2016. Please visit
www.enanta.com for more information on our programs and
pipeline.
Forward Looking Statements DisclaimerThis press release
contains forward-looking statements, including statements with
respect to the prospects for EMA approval of the label expansion
for VIEKIRAX + EXVIERA. Statements that are not historical facts
are based on management’s current expectations, estimates,
forecasts and projections about Enanta’s business and the industry
in which it operates and management’s beliefs and assumptions. The
statements contained in this release are not guarantees of future
performance and involve certain risks, uncertainties and
assumptions, which are difficult to predict. Therefore, actual
outcomes and results may differ materially from what is expressed
in such forward-looking statements. Important factors and risks
that may affect actual results include: the efforts of AbbVie (our
collaborator on paritaprevir that is marketing VIEKIRAX) to obtain
regulatory approval of the label expansion for VIEKIRAX; the
development, regulatory and marketing efforts of others with
respect to competitive HCV treatment regimens; regulatory and
reimbursement actions affecting VIEKIRAX, any competitive regimen,
or both; and other risk factors described or referred to in “Risk
Factors” in Enanta’s most recent Form 10-K for the fiscal year
ended September 30, 2015 and any other periodic reports filed more
recently with the Securities and Exchange Commission. Enanta
cautions investors not to place undue reliance on the
forward-looking statements contained in this release. These
statements speak only as of the date of this release, and Enanta
undertakes no obligation to update or revise these statements,
except as may be required by law.
_________________________________
1 Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin
Microbiol Infect. 2011; 17(2):107-15
2 Global Alert and Response (GAR): Hepatitis C. World Health
Organisation Web site.
http://www.who.int/csr/disease/hepatitis/hepc.pdf. Published 2003.
Accessed February, 2016.
3 O'Leary JG, Davis GL. Hepatitis C. In: Feldman M, Friedman LS,
Brandt LJ, eds. Sleisenger and Fordtran's Gastrointestinal and
Liver Disease: Pathophysiology/Diagnosis/Management. 9th ed, Vol 1.
Philadelphia, PA: Saunders Elsevier. 2010:1313-1335
4 Hatzakis, A. et. al. The state of hepatitis B and C in Europe:
report from the hepatitis B and C summit conference. Journal of
Viral Hepatitis, 2011; 18 (Suppl. 1): 1-16
5 Feld JJ, Moreno C, Trinh R, et al. Sustained virologic
response of 100% in HCV genotype 1b patients with cirrhosis
receiving ombitasvir/paritaprevir/r and dasabuvir for 12 weeks. J
Hepatol. 2016 Feb;64(2):301-7
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160226005639/en/
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
Enanta Pharmaceuticals (NASDAQ:ENTA)
Historical Stock Chart
From Jun 2024 to Jul 2024
Enanta Pharmaceuticals (NASDAQ:ENTA)
Historical Stock Chart
From Jul 2023 to Jul 2024